关于印发《进一步规范医疗机构药品集中采购工作的意见》的通知
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关于印发《进一步规范医疗机构药品集中采购工作的意见》的通知
关于印发《进一步规范医疗机构药品集中采购工作的意见》的通知
卫规财发[2009]7号
各省、自治区、直辖市卫生厅局、纠风办、发展改革委（物价局）、工商行政管理局、食品药品监管局（药品监管局）、中医药局：
为规范和推动新形势下医疗机构药品集中采购工作，我们制定了《关于进一步规范医疗机构药品集中采购工作的意见》。现印发给你们，请遵照执行。
中华人民共和国卫生部 国务院纠正行业不正之风办公室
中华人民共和国国家发展和改革委员会 中华人民共和国国家工商行政管理总局
国家食品药品监督管理局 国家中医药管理局
二○○九年一月十七日
关于进一步规范医疗机构药品集中采购工作的意见
近几年来，各地结合实际，积极推行医疗机构药品集中采购工作，进行了有益探索，取得了明显成效，但也存在各地发展不平衡、采购政策不统一、采购办法不完善、中介服务成本高等突出问题。为进一步规范医疗机构药品集中采购工作，使其在保证药品质量、控制虚高药价、整顿购销秩序、治理商业贿赂、纠正不正之风、减轻人民群众医药费用负担等方面发挥重要作用，根据中央纪委第十七届三次全会精神和国务院对纠风工作的要求，现提出以下意见：
一、全面实行政府主导、以省（自治区、直辖市）为单位的网上药品集中采购工作
药品是维护人民健康的特殊商品，与群众利益密切相关。各级政府对药品集中采购工作要切实加强领导，积极发挥主导作用。各省（区、市）人民政府负责组织建立药品集中采购工作领导机构、工作机构和非营利性的药品集中采购平台，确保采购平台功能完善、设施齐全，并对药品集中采购工作机构的人员编制、经费补助等给予积极支持。有条件的地区可建立财政全额补助的集中采购机构，具体负责药品集中采购的实施工作，形成政府组织推动、医疗机构和药品生产流通企业通过采购平台直接免费交易的购销方式。
医疗机构药品集中采购工作，要以省（区、市）为单位组织开展。县及县以上人民政府、国有企业（含国有控股企业）等所属的非营利性医疗机构，必须全部参加药品集中采购。鼓励其他医疗机构参加药品集中采购活动。药品集中采购要充分考虑各级各类医疗机构的临床用药需求特点。集中采购周期原则上一年一次。
全面推行网上集中采购，提高医疗机构药品采购透明度。医疗机构按申报集中采购药品的品种、规格、数量，通过药品采购平台采购所需的药品。
二、规范集中采购药品目录和采购方式
各省（区、市）要制定药品集中采购目录。列入国家基本药物目录的药品，按照国家基本药物制度规定执行。国家实行特殊管理的第二类精神药品、医疗用毒性药品和放射性药品等少数品种以及中药材和中药饮片等可不纳入药品集中采购目录，麻醉药品和第一类精神药品不纳入药品集中采购目录。除上述药品外，医疗机构使用的其他药品原则上必须全部纳入集中采购目录。
对纳入集中采购目录的药品，实行公开招标、网上竞价、集中议价和直接挂网（包括直接执行政府定价）采购。对经过多次集中采购、价格已基本稳定的药品，可采取直接挂网采购的办法，具体品种由省级集中采购管理部门确定。
三、建立科学的药品采购评价办法
集中采购药品要建立科学的评价办法，坚持“质量优先、价格合理”的原则，合理划分药品类别，加大质量分权重，并考虑临床疗效、质量标准、科技水平等因素，对药品的质量、价格、服务和信誉等进行综合评价。省级卫生行政部门要汇总提出本地区有关医疗机构集中采购药品的品种、规格和数量，保证医疗机构的临床用药，满足人民群众多样化的用药需求。进一步做好专家库建设和专业分类管理工作。
四、减少药品流通环节
药品集中采购由批发企业投标改为药品生产企业直接投标。由生产企业或委托具有现代物流能力的药品经营企业向医疗机构直接配送，原则上只允许委托一次。如被委托企业无法向医疗机构直接配送时，经省级药品集中采购管理部门批准，可委托其他企业配送。
五、认真履行药品购销合同
医疗机构要与中标（入围）药品生产企业或其委托的批发企业签订药品购销合同，明确品种、规格、数量、价格、回款时间、履约方式、违约责任等内容。合同采购数量要以医疗机构上年度的实际药品使用数量为基础，适当增减调整后确定。
药品企业和医疗机构必须严格按照《合同法》等规定，履行药品购销合同规定的责任和义务，合同周期一般不低于1年。医疗机构必须按照药品购销合同确定的品种、数量、价格和供货渠道采购使用药品，不得擅自采购非中标（入围）药品；必须严格按照合同约定的时间及时回款，回款时间从货到之日起最长不超过60天。药品企业未按合同生产供应药品或医疗机构未按合同规定采购药品以及逾期不能回款的，都应支付一定比例的违约金（具体比例由省级药品集中采购机构确定）。情节严重的要公示警告并依法追究责任。积极探索采用银行承兑汇票等多种方式规范医疗机构货款结算。
六、规范医疗机构合理用药
医疗机构要加强处方开具和药品使用的规范化管理，提高处方质量，规范医务人员用药行为，纠正为追求经济利益而滥用药物的问题。强化监督检查，推行医疗机构药品用量动态监测、超常预警、处方点评等制度，坚决查处大处方等损害群众利益的行为，保障患者用药安全。
对于部分常用药、廉价药，医疗机构可按照政府规定的最高零售价格销售，具体品种由省级集中采购管理部门确定。
七、落实部门责任，严格监督管理
各地区有关部门要密切协作，加大监管力度。卫生行政部门牵头组织药品集中采购工作，并负责对医疗机构执行中标（入围）结果和履行合同情况进行监督检查；物价管理部门负责对收费行为、中标（入围）药品零售价格的核定及执行情况进行监督检查；工商行政管理部门负责对药品集中采购及招投标过程中的商业贿赂等不正当竞争行为进行监督检查；药监部门负责药品企业的资质认定，并对中标（入围）药品的质量和配送情况进行监督检查；纠风部门负责对药品集中采购的全过程进行监督，受理有关药品集中采购的检举和投诉，并对违纪违法行为进行调查处理。各部门要加强协调配合，及时研究解决药品集中采购工作中出现的重大问题。
各地区有关部门要通过采购平台，对医疗机构采购药品的品种、数量、价格、加价率、回款、使用和药品企业参与投标、供应药品等情况进行动态监管，使药品采购全过程公开透明。要定期检查，发现问题及时解决。要及时受理并认真调查处理有关投诉。对在药品集中采购中违反有关政策和规定的机构和有关人员，一经发现，要严肃追究责任。
本意见自印发之日起施行。以前所发药品集中采购文件与本意见不一致的，按本意见规定执行。
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外商投资城市规划服务企业管理规定(附英文)
中华人民共和国建设部
中华人民共和国对外贸易经济合作部 令
第116号
《外商投资城市规划服务企业管理规定》已经2002年12月13日建设部第65次常务会议和2003年1月30日对外贸易经济合作部第2次部长办公会议审议通过，现予发布，自2003年5月1日起施行。
建设部部长 汪光焘
对外贸易经济合作部部长 石广生
二○○三年二月十三日
外商投资城市规划服务企业管理规定
第一条 为进一步扩大对外开放，规范外国公司、企业和其他经济组织或者个人投资城市规划服务企业，加强对外商投资城市规划服务企业从事城市规划服务活动的管理，根据《中华人民共和国外资企业法》、《中华人民共和国中外合资经营企业法》、《中华人民共和国中外合作经营企业法》、《中华人民共和国城市规划法》，制定本规定。
第二条 在中华人民共和国境内设立外商投资城市规划服务企业，申请《外商投资企业城市规划服务资格证书》，实施对外商投资城市规划服务企业监督管理，适用本规定。
第三条 本规定所称外商投资城市规划服务企业，是指在中华人民共和国依法设立，从事城市规划服务的中外合资、中外合作经营企业以及外资企业。
本规定所称城市规划服务，是指从事除城市总体规划以外的城市规划的编制、咨询活动。
第四条 外国公司、企业和其他经济组织或者个人在中国从事城市规划服务，必须依法设立中外合资、中外合作或者外资企业，取得《外商投资企业城市规划服务资格证书》。
未取得《外商投资企业城市规划服务资格证书》的，不得从事城市规划服务。
第五条 国务院对外贸易经济行政主管部门负责外商投资城市规划服务企业设立的管理工作；国务院建设行政主管部门负责外商投资城市规划服务企业资格的管理工作。
省、自治区、直辖市人民政府对外贸易经济行政主管部门负责本行政区域内外商投资城市规划服务企业设立的初审工作；县级以上地方人民政府城市规划行政主管部门负责对本行政区域内的外商投资城市规划服务企业从事城市规划服务活动的监督管理。
第六条 设立外商投资城市规划服务企业，除具备中国有关外商投资企业法律法规规定的条件外，还必须具备以下条件：
（一）外方是在其所在国或者地区从事城市规划服务的企业或者专业技术人员；
（二）具有城市规划、建筑、道路交通、园林绿化以及相关工程等方面的专业技术人员20人以上，其中外籍专业技术人员占全部专业技术人员的比例不低于25％，城市规划、建筑、道路交通、园林绿化专业的外籍专业技术人员分别不少于1人；
（三）有符合国家规定的技术装备和固定的工作场所。
第七条 申请设立外商投资城市规划服务企业的，应当依法向国家工商行政管理总局或者国家工商行政管理总局授权的地方工商行政管理局，申请拟设立外商投资企业名称的核准。
第八条 申请人在取得拟设立外商投资企业名称核准后，向拟设立企业所在地省、自治区、直辖市人民政府对外贸易经济行政主管部门，提出设立外商投资城市规划服务企业申请，并提交下列材料：
（一）投资方法定代表人签署的外商投资企业设立申请书；
（二）投资方编制或者认可的可行性研究报告、项目建议书及企业设立方案（包括专业人员配备、技术装备计划和工作场所面积等）；
（三）投资方法定代表人签署的外商投资企业合同和章程（其中外资企业只需提供章程）；
（四）企业名称预先核准通知书；
（五）投资方法人登记注册证明、投资方银行资信证明；
（六）投资方拟派出的董事长、董事会成员、经理、工程技术负责人等任职文件及证明文件；
（七）经注册会计师或者会计师事务所审计的投资方最近三年的资产负债表和损益表；
（八）外方投资者所在国家或者地区从事城市规划服务的企业注册登记证明、银行资信证明；
（九）外方投资者所在国家或者地区政府主管部门或者行业协会、学会、公证机构出具的从事城市规划服务经历及业绩的证明。
第九条 省、自治区、直辖市人民政府对外贸易经济行政主管部门，在受理申请之日起30日内完成初审；初审同意后，报国务院对外贸易经济行政主管部门。
第十条 国务院对外贸易经济行政主管部门，在接到经初审的申请材料之日起10日内，将申请材料送国务院建设行政主管部门征求意见。国务院建设行政主管部门收到申请材料之日起30日内提出意见。国务院对外贸易经济行政主管部门在收到国务院建设行政主管部门书面意见之日起30日内作出批准或者不批准的决定。予以批准的，发给外商投资企业批准证书；不予批准的，书面说明理由。
第十一条 申请人在取得外商投资企业批准证书后，依法办理企业工商注册登记，领取营业执照。
第十二条 申请人在取得企业法人营业执照后，向国务院建设行政主管部门申请《外商投资企业城市规划服务资格证书》。
第十三条 申请《外商投资企业城市规划服务资格证书》应当提供下列材料：
（一）《外商投资企业城市规划服务资格证书》申请表；
（二）外商投资企业批准证书；
（三）企业法人营业执照；
（四）经劳动人事部门备案的专业技术人员聘用合同和专业技术资格证明材料；
（五）企业技术装备材料。
第十四条 外商投资城市规划服务企业应当在取得《外商投资企业城市规划服务资格证书》后30日内，向其注册所在市、县城市规划行政主管部门备案。
第十五条 外商投资城市规划服务企业承揽注册所在地以外城市规划服务任务的，应当向任务所在市、县城市规划行政主管部门备案。
第十六条 申请人提交的材料应当使用中文，证明文件是外文的，必须提供中文译本。
第十七条 外商投资城市规划服务企业从事城市规划服务，必须遵守中国有关城市规划的法律法规、技术标准和规范。
第十八条 外商投资城市规划服务企业聘用的外国技术人员每人每年在中国境内累计居留时间不少于6个月。
第十九条 国务院建设行政主管部门对取得《外商投资企业城市规划服务资格证书》的外商投资城市规划服务企业，每年进行一次年检。对不符合资格条件的，收回其《外商投资企业城市规划服务资格证书》。
第二十条 已取得《城市规划编制单位资质证书》的中方单位，改组、改制成立中外合资、中外合作城市规划服务企业的，应当交回《城市规划编制单位资质证书》。
第二十一条 外商投资城市规划服务企业停业、撤销、终止时，应当交回《外商投资企业城市规划服务资格证书》。
第二十二条 严禁将城市规划服务任务委托给未取得《外商投资企业城市规划服务资格证书》的外商投资企业。
严禁将有关城市总体规划的服务任务委托给外商投资企业。
第二十三条 未取得《外商投资企业城市规划服务资格证书》承揽城市规划服务任务的，由县级以上地方人民政府城市规划行政主管部门责令停止违法活动，处1万元以上3万元以下的罚款。对其成果，有关部门不得批准。
第二十四条 外商投资城市规划服务企业违反本办法规定从事城市总体规划编制服务的，由县级以上地方人民政府城市规划行政主管部门责令改正；情节严重的，由发证机关收回《外商投资企业城市规划服务资格证书》。
外商投资城市规划服务企业弄虚作假，骗取《外商投资企业城市规划服务资格证书》的，由发证机关收回资格证书。
发证机关收回资格证书后，应当将有关情况通报注册登记机关。被收回资格证书的企业，应当向注册登记机关申请注销登记；不办理注销登记的，由注册登记机关依法处理。
第二十五条 违反本规定，将城市规划服务任务委托给未取得《外商投资企业城市规划服务资格证书》外商投资企业的，或者将总体规划服务任务委托给外商投资城市规划服务企业的，由上级机关予以纠正，依法追究有关责任人的行政责任；构成犯罪的，依法追究刑事责任。
第二十六条 本规定由国务院建设行政主管部门、国务院对外贸易经济行政主管部门按照各自的职责负责解释。
第二十七条 香港特别行政区、澳门特别行政区和台湾地区的投资者在大陆投资兴办城市规划服务企业的，参照本规定执行。
第二十八条 本规定自2003年5月1日起施行。
Regulations on the Management of Foreign-funded Urban Planning Service Enterprises
Decree of the Ministry of Construction and the Ministry of Foreign Trade and Economic Cooperation,
No 116
The Regulations on the Management of Foreign-funded Urban Planning Service Enterprises, deliberated and ratified at the 65th executive meeting of the Ministry of Construction on December 13th, 2002 and the 2nd working meeting of the minister of Foreign Trade and Economic Cooperation on January 30th, 2003, is hereby promulgated for implementation as of May 1st, 2003.
Wang Guangtao, Minister of Construction
Shi Guangsheng, Minister of Foreign Trade and Economic Cooperation
February 13th, 2003
Regulations on the Management of
Foreign-funded Urban Planning Service Enterprises
Article 1 Pursuant to 《the Law of the People's Republic of China on Foreign-funded Enterprises》,《the Law of the People's Republic of China on Sino-foreign Equity Joint Ventures》,《the Law of the People's Republic of China on Sino-foreign cooperative Joint Ventures》, and《the Law of the People's Republic of China on Urban Planning》, the current Regulations is hereby formulated to expand the scope of opening to the outside; regulate foreign companies, enterprises and other economic entities or individuals investing in enterprises providing services to urban planning; and strengthen management of the activities of urban planning services provided by foreign-funded urban planning service enterprises.
Article 2 The Regulations applies to those setting up foreign-funded urban planning service enterprises within the boundary of the People's Republic of China and applying for the 《Certificate of Qualification of Foreign-funded Enterprises for Urban Planning Services》, and to the supervision and management of foreign-funded urban planning service enterprises.
Article 3 The foreign-funded urban planning service enterprises as referred to in the current Regulations include Sino-foreign equity joint ventures, Sino-foreign cooperative joint ventures, and ventures with exclusive foreign investment that are set up in the People's Republic of China in accordance with law to provide services to urban planning.
The term 'urban planning service' as used in the current Regulations refers to provide drawing and consulting services to urban development plans other than general planning.
Article 4 All foreign companies, enterprises, other economic entities or individuals engaged in urban planning services in China shall set up Sino-foreign equity joint ventures, Sino-foreign cooperative joint ventures, or ventures with exclusive foreign investment and apply for the 《Certificate of Qualification of Foreign-funded Enterprises for Urban Planning Services》.
Those have not been granted the 《Certificate of Qualification of Foreign-funded Enterprises for Urban Planning Services》 shall not take up the business of urban planning services.
Article 5 The department responsible for the management of foreign trade and economic cooperation under the State Council shall take charge of management of establishment of foreign-funded urban planning service enterprises, while the department responsible for construction under the State Council shall take charge of management of qualification of foreign-funded urban planning service enterprises.
The departments responsible for foreign trade and economic cooperation under the people's governments at the provincial, autonomous regional and municipal governments under the direct leadership of the central government shall take charge of preliminary examination of establishment of foreign-funded urban planning service enterprises in their respective administrative areas, and departments responsible for urban planning under people's governments at and above the county level shall take charge of supervision and management of the urban planning service activities carried out by foreign-funded urban planning service enterprises in their respective administrative areas.
Article 6 Apart from meeting requirements set in relevant Chinese laws and regulations on foreign-funded enterprises, the following requirements shall be met for the establishment of foreign-funded urban planning service enterprises:
1. The foreign party shall be an enterprise or professional specializing in urban planning services in its resident country or region.
2. The applicant shall own more than 20 employees specializing in urban planning, architecture, road transportation, gardening and related disciplines, with foreign specialists accounting for no less than 25 percent of the total, and have at least one foreign technician specializing in urban planning, architecture, road transportation, and gardening respectively.
3. The applicant shall have technical apparatus and fixed working site as stipulated by the State.
Article 7 Those applying for establishing foreign-funded urban planning service enterprises shall apply, in accordance with law, to the State Administration of Industry and Commerce or local administrations of industry and commerce with authorization from the State Administration of Industry and Commerce for examination and approving the titles of the foreign-funded enterprises they plan to set up.
Article 8 After passing examination and receiving approval of the titles of the foreign-funded enterprises it plans to set up, the applicant shall apply to the departments of the provincial, autonomous regional or people's municipal government under the direct leadership of the central government in charge of foreign trade and economic cooperation in the region where the enterprise is to be located for the establishment. it shall submit the following documents:
1. The application for the establishment of a foreign-funded enterprise signed by the legal representative of the investing party.
2. The feasibility study report, project proposal and plan on the establishment of the enterprise (including staffing of specialists, plan on technical equipment, and area of the working site) produced or approved by the investing party.
3. The contract and rules of the foreign-funded enterprise signed by the legal representative of the investing party (or rules only, in the case of an enterprise with exclusive foreign investment).
4. Notice of pre-approval on the title of the enterprise to be set up.
5. Certificate of legal person registration of the investing party and certificate of the credit provided by the bank of the investing party.
6. Documents and certificates of appointment of the chairman, board members, managers, and leading engineers or technicians to be appointed by the investing party.
7. The balance sheets and statements of loss and gain of the investing party during the latest three years as audited by a chartered accountant or an accountant firm.
8. Certificate of registration and certificate of bank credit of the urban planning service enterprise(s) run by the foreign investing party in its country or region.
9. Certificates of experiences and achievements of the foreign investing party in urban planning services produced by responsible government departments or associations, societies, or notary organs in the residential country or region of the said party.
Article 9 The department under provincial, autonomous regional or people's municipal governments under the direct leadership of central government in charge of foreign trade and economic cooperation shall complete preliminary examination within 30 days after receiving an application and submit its approval to the State Council department in charge of foreign trade and economic cooperation.
Article 10 The State Council department in charge of foreign trade and economic cooperation shall submit the application documents that have passed preliminary examination and approval to the State Council department in charge of construction for soliciting the comments within 10 days. The State Council department in charge of construction shall put forward its opinion within 30 days after receiving the application documents. Within 30 days after receiving the written opinion of the State Council department in charge of construction, the State Council department in charge of foreign trade and economic cooperation shall make a decision of approval or disapproval. In the case of approval, a certificate of approval shall be issued; and in the case of disapproval, a written explanation shall be given.
Article 11 After receiving the Certificate of Approval of Foreign-funded Enterprise, the applicant shall register with an administration of industry and commerce in accordance with law to get a business license.
Article 12 After receiving a legal person business license, the applicant shall apply to the State Council department in charge of construction for the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》.
Article 13 The following documents shall be supplied for application for the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》:
1. Form of Application for the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》;
2. Certificate of Approval of Foreign-funded Enterprise;
3. Business license for enterprise legal person;
4. Contract of employment of technicians and specialists and certificates of technical qualifications of these people put on file in labour and personnel departments;
5. Documents about the technical equipment of the enterprise.
Article 14 The foreign-funded urban planning service enterprise shall report, within 30 days after receiving the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》, to the urban planning administration in the city or county of its registered for the record.
Article 15 The foreign-funded urban planning service enterprise that contracts for urban planning services in areas other than that of its registration shall report to the urban planning administrations of these areas for the record.
Article 16 All the documents submitted by the applicant shall be written in Chinese. If any document of certification is written in a foreign language, a Chinese version shall be supplied.
Article 17 Foreign-funded urban planning service enterprises shall abide themselves by pertinent Chinese laws, regulations, and technical standards and norms when providing urban planning services.
Article 18 The foreign technicians employed by foreign-funded urban planning service enterprises shall stay in China for a total length of no less than 6 months per person a year.
Article 19 The State Council department in charge of construction shall carry out annual checks to the foreign-funded urban planning service enterprises that have received the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》. Those found unqualified shall have their 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》 revoked.
Article 20 Chinese units that have received the 《Certificate of Qualification for Compilation of Urban Planning》 shall hand in the Certificate when they are restructured into Sino-foreign equity or cooperative joint ventures specializing in urban planning services.
Article 21 Foreign-funded urban planning service enterprises shall hand in their 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》 when they stop operations or are disbanded or terminated.
Article 22 It is strictly forbidden to entrust any businesses of urban planning services to foreign-funded enterprises that have not granted the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》.
It is strictly forbidden to entrust any businesses of service to general urban planning to foreign-funded enterprises.
Article 23 Those that contract for urban planning services without the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》 shall be ordered by the construction administrations of people's governments at or above the county level to stop their illegal activities, together with a penalty above RMB10,000 yuan and below RMB30,000 yuan. Their achievements shall not be acknowledged by any department.
Article 24 Those foreign-funded urban planning service enterprises that provide services to compilation of general urban planning in violation of the current Regulations shall be ordered by the construction administrations of people's government at or above the county level to mend themselves. Those involved in severe cases shall have their 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》withdrawn by the original issuer.
Those foreign-funded urban planning service enterprises that obtain the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》 through fraud and deception shall have their Certificate withdrawn by the issuer.
After withdrawing a Certificate, the issuer shall inform the registration department concerned of the case. The enterprise whose certificate has been withdrawn shall apply to the original department of registration for cancellation of its registration. Those that refuse to go through cancellation formalities shall be handled by registration departments in accordance with law.
Article 25 Those that entrust urban planning services or general urban planning services to foreign-funded enterprises that have not got the 《Certificate of Qualification for Urban Planning Services for Foreign-funded Enterprises》 in violation of the current Regulations shall be corrected by their senior departments, with administrative responsibilities to be affixed upon the person responsible in accordance with law. If a crime is committed, criminal responsibilities shall be found out in accordance with law.
Article 26 The current Regulations shall be interpreted by the State Council department in charge of construction and the State Council department in charge of foreign trade and economic cooperation according to their respective functions.
Article 27 Investors from the Hong Kong Special Administrative Zone, the Macao Special Administrative Zone, and Taiwan area coming to run urban planning service enterprises on the mainland shall be handled with reference to the current Regulations.
Article 28 The current Regulations shall take effect as of May 1, 2003.
To be sent to: The Law Committee of the National People's Congress, the Law Office of the State Council, the Editorial Office of the Gazette of the State Council, the construction commissions and bureaus of foreign trade and economic cooperation of people's governments at the provincial, autonomous regional and municipal level, the construction commission of cities as independent entries in State plans and budgets, ministries and commissions of the State Council, and leaders, bureaus, and subsidiary institutions of the Ministry of Construction.
Secretariat of the General Office of the Ministry of Construction
Printed and issued on February 20th, 2003
关于推动药品生产企业实施药品质量受权人制度的通知
关于推动药品生产企业实施药品质量受权人制度的通知
国食药监安[2009]121号
各省、自治区、直辖市食品药品监督管理局（药品监督管理局）：
为贯彻中央经济工作会议精神，落实2009年全国食品药品监督管理工作会议确定的工作部署，进一步加强药品生产监督管理，规范药品生产秩序，确保药品生产质量，维护人民群众用药安全，国家局决定在药品生产企业实行药品质量受权人制度。现将有关事项通知如下：
一、药品质量受权人制度是药品生产企业授权其药品质量管理人员对药品质量管理活动进行监督和管理，对药品生产的规则符合性和质量安全保证性进行内部审核，并由其承担药品放行责任的一项制度。实行药品质量受权人制度是强化药品生产企业内部质量管理机制，明确质量责任，提高企业质量管理水平的有效措施，也是进一步强化企业是质量第一责任人责任意识的有效手段。各省、自治区、直辖市食品药品监督管理局应高度重视在药品生产企业实行药品质量受权人制度，将此项工作纳入2009年药品安全监管工作的重点，深入研究，精心组织，周密部署，扎扎实实做好辖区内药品生产企业药品质量受权人制度的推广实施工作。
二、结合我国药品生产的实际情况，在药品生产企业实行药品质量受权人制度工作采取“分阶段逐步推行”的原则。2009年将首先在血液制品类、疫苗类、注射剂类以及重点监管特殊药品类药品生产企业试行药品质量受权人制度。各省局可结合辖区内药品生产的实际情况，扩大药品质量受权人制度推广实施范围。
三、药品质量受权人应具有药学或相关专业大学本科以上（含本科）学历或具有中级以上（含中级）相关专业技术职称，并具有五年以上（含五年）药品生产和质量管理实践经验，熟悉和了解企业自有产品生产工艺和质量标准。其主要职责包括：遵守和实施有关产品质量的法规或技术要求，负责最终产品的批放行，参与或负责药品研发和技术改造，实施（必要时并建立）质量体系，监控企业内部的质量审计或自检，监管质量控制部门，同时还应参与外部质量审计（供应商审计）、参与验证以及药品不良反应报告、产品召回等工作。
四、药品质量受权人经培训后方能上岗履行其相应职责，并应主动参加所在地食品药品监督管理部门组织的各项培训。药品质量受权人的培训由所在地省级食品药品监督管理局组织，国家局统一编制培训教材并为各省局培训师资。
五、药品质量受权人暂行报告制度。血液制品类、疫苗类、注射剂类和重点监管特殊药品类药品生产企业应将确定的药品质量受权人的相关情况，向企业所在地省级食品药品监督管理部门报告。企业因故变更药品质量受权人的，应及时将变更情况及相关问题向报告部门予以说明。各省局应将企业提交的药品质量受权人情况报告纳入企业监管档案，作为日常监管的依据。
六、各省局应认真做好实施药品质量受权人制度的宣传与动员，加强与药品生产企业的沟通，引导企业建立和完善以药品GMP为核心，药品质量受权人、质量保证和质量控制等部门协调统一、发挥相关职能作用的质量管理体系，并将药品质量受权人制度实施情况纳入药品GMP认证及跟踪检查日常监管工作中，强化企业质量第一责任人的意识，明确质量管理责任，确保药品质量。
七、各省局应结合本辖区药品生产监管实际，借鉴一些省局已试行或试点实施药品质量受权人制度的经验，以科学发展观为指导，积极探索，勇于实践，创造性地开展实施药品质量受权人制度工作。同时，应注重加强法规建设，并探索将派驻监督员制度与药品质量受权人制度相结合的管理模式，不断创新药品安全监管长效机制。
实施工作中有何问题或建议，请及时与国家局药品安全监管司联系。
国家食品药品监督管理局
二○○九年四月八日
